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FDA 510(k) Applications for Medical Device Product Code "OWW"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K160364
Alafair Biosciences Inc
VersaWrap Tendon Protector
06/10/2016
K240817
Alafair Biosciences Inc.
VersaWrap
06/14/2024
K222220
CelestRay Biotech Company, LLC
SpinMedix Absorbable Fibrous Membrane
07/06/2023
K242187
CONMED Corporation
BioBrace«
11/27/2024
K241906
CONMED Corporation
BioBrace« Reinforced Implant
07/29/2024
K230316
International Life Sciences
FlexBand; FlexPatch; FlexBand Plus
05/26/2023
K250021
Nanofiber Solutions, LLC
Rotium
02/27/2025
K121216
SOFT TISSUE REGENERATION, INC.
STR GRAFT
11/21/2012
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